| CTRI Number |
CTRI/2019/11/021900 [Registered on: 06/11/2019] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison between 3 surgical treatments in stable vitiligo patients |
|
Scientific Title of Study
|
A comparative study of the efficacy and safety of follicular unit transplantation, ultrathin skin grafting
and dermabrasion combined with topical 5-FU in stable vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishi Trivedi |
| Designation |
Post graduate student |
| Affiliation |
GCS Medical College, Hospital and research centre |
| Address |
Opd no.35, GCS hospital main building,GCS medical college, hospital and research center, opp DRM office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
nishi.trivedi04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjan Raval |
| Designation |
Professor and guide |
| Affiliation |
GCS Medical College, Hospital and research centre |
| Address |
Opd no. 36, GCS hospital main building, GCS medical college, hospital and research center, opp DRM office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
ranjanmb@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishi Trivedi |
| Designation |
Post graduate student |
| Affiliation |
GCS Medical College, Hospital and research centre |
| Address |
Opd 35, GCS hospital main building, GCS medical college, hospital and research center, opp DRM office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
nishi.trivedi04@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS medical college, hospital and research center, Opp DRM office, Naroda road, Ahmedabad 380025 |
|
|
Primary Sponsor
|
| Name |
GCS Medical college Hospital and Research center |
| Address |
GCS medical college, hospital and research center, opp DRM office, Naroda road, Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishi Trivedi |
GCS Medical college, hospital and research center |
Department of dermatology, OPD no. 35, GCS hospital, Opp DRM office, Nr Chamunda bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT |
9328061865
nishi.trivedi04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GCS Medical college, Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dermabrasion combined with topical 5FU |
Vitiligo patch is dermabraded following which patient is asked to apply on local part 5 fluorouracil twice a day |
| Intervention |
Follicular unit transplantation |
Follicular unit transplantation
(FUT) is a surgical technique that relies on providing a reservoir of undifferentiated
stem cells to the depigmented lesional skin. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ultrathin skin grafting |
Ultrathin skin grafting (UTSG) is a special modification of split thickness skin grafting (STSG) wherein a very thin skin graft composed entirely of the epidermis without any dermal tissue is transplanted on to the dermabraded vitiligo lesion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with stable vitiligo ( no new lesions, no progression of existing lesions for past 1 year)
2. Patients >18 years |
|
| ExclusionCriteria |
| Details |
1. Patients with active vitiligo
2. Patients with history of Koebner phenomenon
3. Patients with keloidal tendency
4. Patients with a history of bleeding disorders
5. Presence of concomitant local or systemic infections
6. Presence of uncontrolled diabetes
7. Pregnant or lactating patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Response evaluation:
1.By calculating the percentage area of reduction in the area of vitiligo.
This will be done at every follow-up.
2.Qualitative assessment:
0-25 – poor response (grade 1)
25-50 – fair response (grade 2)
50-75 – good response (grade 3)
75-100 – excellent response (grade 4)
4. Hair repigmentation |
Every month after procedure for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of any side effects including infection, graft loss, healing delay, extension of lesion |
Every month after procedure for 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational, comparative, randomised tertiary care hospital based prospective study of stable vitiligo patients presenting to the department of dermatology treated with either one of follicular unit transplantation, ultrathin skin grafting or dermabrasion followed by topical 5-flurouracil. The aim is to observe and compare the efficacy of Follicular Unit Transplantation, ultrathin skin grafting and dermabrasion followed by topical 5-flurouracil in patients of stable vitiligo. Randomisation: the participants will be randomised in 3 groups by sequential allocation. If the participant has any contraindication to the allotted group, participant will be allotted to next group on discretion of the principal investigator. |